BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1221527 · Received November 5, 2008

    Report

    Report Number
    9611451-2008-00654
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    July 29, 2008
    Report Date
    October 6, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE CURRENTLY OBTAINING MORE INFO REGARDING THIS EVENT. WE WILL PROVIDE A F/U REPORT.

    Description of Event or Problem · 1

    A HOSP REPORTED VIA OUR DISTRIBUTOR THAT THERE WAS TOO MUCH CONDENSATION WITH AN MR850 RESPIRATORY HUMIDIFIER. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR850

    Patients

    Seq Age Sex Outcome Treatment
    1